(57 days)
Not Found
No
The document describes a mechanical implant (cervical plate system) and its intended use and materials. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is described as "intended for anterior intervertebral screw fixation of the cervical spine" and "for temporary stabilization of the anterior spine during the development of cervical spine fusions" for various medical conditions, clearly indicating a therapeutic purpose to treat or stabilize medical conditions.
No
The device is an implantable plate system for temporary stabilization of the cervical spine during fusion, and is not used to diagnose conditions.
No
The device description clearly details physical components made of titanium alloy (plates and screws) intended for surgical implantation. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior intervertebral screw fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spine fusions." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details physical components like plates and screws made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with biological specimens for diagnostic purposes.
The device described is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MSFX Mikron Cervical Anterior Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
-Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures)
-Tumors
-Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
-Pseudarthrosis
-Failed previous fusion
-Decompression of the spinal cord following total or partial cervical vertebrectomy
-Spondylolisthesis
-Spinal stenosis.
Product codes
KWQ
Device Description
The MSFX Cervical Anterior Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The MSFX Mikron cervical anterior plate configurations ranging in lengths from 17 mm to 25 mm for the one-level plates, 27 mm to 40 mm for the two-level plates, 45 mm to 65 mm for the three-level plates, and 70 mm to 90 mm for the four -level plates All of the plate levels incorporate blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with fixed angles available in self- tapping design. The fixed bone screws are inserted at a defined angle. The bone screws are offered in 3.5mm, 4.0mm and 4.5 mm of diameters in lengths of 12 mm - 20 mm. All components made of Ti alloy are subjected to anodizing. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (Ti6Al4V).
The MSFX Cervical Anterior Plate System is supplied non-sterilized by end-user by moist-heat, is for single use and is fabricated from titanium alloy (Ti6Al4V-ELD) that conforms to ASTM F136. Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine at levels C2-T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional in a healthcare facility/ hospital.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing including Fatigue Test (ASTM F1717-18) Static Compression Test (ASTM F1717-18), and Static Torsion Test (ASTM F1717-18) were conducted on the predicate device (K211718). As the purpose of this submission is to rebrand the Venus Cervical Plate System (K211718), no new mechanical testing is needed on the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
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Mikron Makina Sanayi ve Ticaret Ltd. Sti. Mustafa Ekiz Medical Devices Manager Ivedik OSB Mahallesi 1372. Sok No:31 Yenimahalle Ivedik, Ankara 06378 Turkev
Re: K240484
Trade/Device Name: MSFX Mikron Cervical Anterior Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 9, 2024 Received: February 20, 2024
Dear Mustafa Ekiz:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
April 17, 2024
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
MSFX Mikron Cervical Anterior Plate System
Indications for Use (Describe)
The MSFX Mikron Cervical Anterior Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
-Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures)
-Tumors
-Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
-Pseudarthrosis
-Failed previous fusion
-Decompression of the spinal cord following total or partial cervical vertebrectomy
-Spondvlolisthesis
-Spinal stenosis.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
Contact Person/Applicant:
NAME: MUSTAFA EKIZ
COMPANY NAME: MIKRON MAKINA SANAYI VE TICARET LTD. STI.
ADDRESS: Ivedik OSB Mahallesi 1372. Sok. No:31 Ostim/ Yenimahalle/ Ankara/ Turkey
PHONE: +90 3128020066
FAX: +90 312 3958729
EMAIL: mustafaekiz@mikronmakina.com
ESTABLISHMENT REGISTRATION:3010646402
Secondary Contact Person: NAME: James Gibson, PHD, CPA, COMPANY NAME: SAGICO VA USA, LLC ADDRESS: 2189 W Busch Blvd Tampa, FL 33612 PHONE- Cell: 813-505-7800 EMAIL: JG@SAGICOUSA.com
DEVICE IDENTIFICATION
TRADE NAME: MSFX MIKRON CERVICAL ANTERIOR PLATE SYSTEM CLASSIFICATION NAME: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY REGULATION NUMBER: 888.3060 REVIEW PANEL: ORTHOPEDIC PRODUCT CODE: KWQ REASON FOR SUBMISSION: NEW DEVICE (to be rebranded from the primary predicate device)
4
INDICATIONS FOR USE:
The MSFX Cervical Anterior Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
-Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-Trauma (including fractures)
-Tumors
-Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
-Pseudarthrosis
-Failed previous fusion
-Decompression of the spinal cord following total or partial cervical vertebrectomy
-Spondylolisthesis
-Spinal stenosis.
DEVICE DESCRIPTION:
The MSFX Cervical Anterior Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The MSFX Mikron cervical anterior plate configurations ranging in lengths from 17 mm to 25 mm for the one-level plates, 27 mm to 40 mm for the two-level plates, 45 mm to 65 mm for the three-level plates, and 70 mm to 90 mm for the four -level plates All of the plate levels incorporate blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with fixed angles available in self- tapping design. The fixed bone screws are inserted at a defined angle. The bone screws are offered in 3.5mm, 4.0mm and 4.5 mm of diameters in lengths of 12 mm - 20 mm. All components made of Ti alloy are subjected to anodizing. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (Ti6Al4V).
The MSFX Cervical Anterior Plate System is supplied non-sterilized by end-user by moistheat, is for single use and is fabricated from titanium alloy (Ti6Al4V-ELD) that conforms to ASTM F136. Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.
NON-CLINICAL TESTING:
Non-clinical testing including Fatigue Test (ASTM F1717-18) Static Compression Test (ASTM F1717-18), and Static Torsion Test (ASTM F1717-18) were conducted on the predicate device (K211718). As the purpose of this submission is to rebrand the Venus Cervical Plate System (K211718), no new mechanical testing is needed on the subject device.
5
PRIMARY PREDICATE:
TRADE/ DEVICE NAME: VENUS CERVICAL PLATE SYSTEM REGULATION NUMBER: 21 CFR 888.3060 REGULATION NAME: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY REGULATORY CLASS: Class II PRODUCT CODE: KWQ 510(K) NUMBER: K211718
ADDITIONAL PREDICATE:
TRADE/ DEVICE NAME: STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM
REGULATION NUMBER: 21 CFR 888.3060
REGULATION NAME: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
REGULATORY CLASS: Class II
PRODUCT CODE: KWQ
510(K) NUMBER: K083562
TECHNOLOGICAL CHARACTERISTICS :
The MSFX MIKRON CERVICAL ANTERIOR PLATE SYSTEM has similar technological characteristics as the predicate devices, including the materials, design, function, range of sizes, manufacturing process, surgical techniques, and intended use. The minor differences do not present new issues of safety and effectiveness.
CONCLUSION:
Based on the data presented in the subject device is determined to be substantially equivalent to the predicate.